(73 days)
The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
The Sterling OTW Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a high performance balloon catheter for peripheral indications. The device features an ultra low profile, semi-compliant balloon combined with a low profile tip. The catheter is compatible with either 0.014 in (.36 mm) or 0.018 in (.46 mm) guidewires.
The Sterling OTW PTA Balloon Dilatation Catheter is an Over-The-Wire (OTW) catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guide wires 0.014 in or 0.018 in (.36 mm or .46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon.
The balloon lengths are available in 120, 150, 200 and 220 mm sizes with diameters of 5.0, 6.0 and 7.0 mm for each balloon length.
The effective lengths of the balloon catheter are 90 cm and 150 cm. Markers on the 90 cm effective length catheter indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 50 cm and two at 60 cm). Markers on the 150 cm effective length catheter indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 90 cm and two at 100 cm). The proximal portion of the catheter includes one female Luer-lock port connected to the inflation lumen, and one female Luer-lock port for guidewire lumen.
The provided text describes the Sterling OTW PTA Balloon Dilatation Catheter and its performance testing to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list specific numerical acceptance criteria for each test. Instead, it states that "The Sterling OTW PTA Balloon Dilatation Catheter met all acceptance criteria for the bench and biocompatibility testing with results similar to the predicate." This implies that the acceptance criteria were defined by the performance of the predicate device and/or industry standards for such devices.
Therefore, the table will reflect the categories of tests performed and the general statement of performance:
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | MEM Elution Cytotoxicity | Conformance to ISO 10993-1 for short duration contact with blood | Met acceptance criteria, results similar to predicate |
| Hemocompatibility (Direct Contact) | Conformance to ISO 10993-1 for short duration contact with blood | Met acceptance criteria, results similar to predicate | |
| Chemical Characterization-USP Physicochemical | Conformance to ISO 10993-1 for short duration contact with blood | Met acceptance criteria, results similar to predicate | |
| Natural Rubber Latex | Conformance to ISO 10993-1 for short duration contact with blood | Met acceptance criteria, results similar to predicate | |
| Bench (In-vitro) | Bond Integrity | Performance similar to predicate | Met acceptance criteria, results similar to predicate |
| Working Length | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Deflation Time | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Balloon Rated Burst Pressure (RBP) | Same as predicate | Met acceptance criteria, results similar to predicate (Same RBP) | |
| Balloon Multiple Inflation | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Crossing Profile | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Full Catheter Tensile Extension and Deflation | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Balloon Multiple Inflation in a Stent | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Particulate Evaluation | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Proximal Balloon Bond and Shaft Tensile Strength | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Balloon Burst Mode | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Balloon Compliance | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Balloon Nominal Diameter | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Burst in a Stent | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Balloon Body Length | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Guidewire Movement | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Sheath Withdrawal | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Marker Band to Balloon Alignment | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Torque after Conditioning | Performance similar to predicate | Met acceptance criteria, results similar to predicate |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size (number of devices or tests) used for the bench and biocompatibility testing. It only states that these tests were "performed."
- Data Provenance: The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, given the context of a 510(k) summary for a medical device submitted to the FDA (indicating "BOSTON SCIENTIFIC CORPORATION" in Maple Grove, MN, USA), it can be inferred that the testing was likely conducted in the USA (or by a US-affiliated entity) and was prospective for the purpose of this submission. The tests are general performance and biocompatibility tests, not clinical data sets in the traditional sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This question is not applicable to the type of information presented. The performance assessment for this device is based on bench testing and biocompatibility testing, not on the interpretation of medical images or diagnostic outputs that would require human expert consensus as ground truth. The "ground truth" for these tests would be the established engineering specifications and biological safety standards.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the evaluation is based on objective measurements from bench testing and laboratory analysis for biocompatibility, not on subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done for this device. This type of study involves human readers interpreting data, often medical images, to assess the impact of an AI system. The Sterling OTW PTA Balloon Dilatation Catheter is a physical medical device, not an AI or diagnostic imaging tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is not an algorithm or an AI system. Its performance is assessed through physical bench tests and biological assays.
7. Type of Ground Truth Used:
The ground truth for the performance data in this submission is based on:
- Established engineering specifications and design requirements: For bench testing (e.g., burst pressure, dimensions, tensile strength).
- International standards for biocompatibility (ISO 10993-1): For biocompatibility testing.
- Performance of the predicate device: The new device was required to perform "similar to the predicate."
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical device and does not involve AI or machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).